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TSB REALISE Final Report:Methodology for the Analysis of Life Science Innovation Systems (ALSIS) and its Application to Three Case Studies

The REALISE project, funded by the UK Technology Strategy Board, addressed the following questions as they apply to early stage regenerative medicine commercial developments in three case studies based on human embryonic stem cell developments: Pluripotent Stem Cells themselves, a Bio-artificial Liver (BAL) Device and Red Blood Cells (Annexes 1 – 3).

1.) How far the opportunities to realise value for the UK regenerative medicine industry are enhanced or inhibited by factors outside the boundaries of individual businesses or specific value chains;

2.) How value realisation can be critically affected by relationships with sources of finance;

3.) Collaborations with universities, regionally, nationally and internationally;

4.) Logistics, point of care and end user issues; and

5.) Regulatory and fiscal frameworks.

We developed an interdisciplinary methodology that can be applied to the Analysis of Life Science Innovation Systems (ALSIS) in general and applied it to the three case studies as they evolved over the two year period of the project. The methodology provides an overarching framework that acts as a basis for interdisciplinary integration across academic disciplines, across business and stakeholder perspectives and across a wide range of areas of application, in interaction with regulatory, stakeholder and market influences. It links the business models that interact to form a value chain, embedded within a value system that brings in the wider systemic influences on business success. Scenario analysis is then used to assesses the future prospects for value creation for an RM therapy, taking account of the actors, roles and ambitions involved at different levels in the overall value system.